Quality Assurance Engineer

• Support manufacturing business functions in product quality and environmental compliance acrossdedicated operational areas.
• Act as a local quality partner for discussions related to PFMEA, non-conformances, CAPAs, productquality, and safety requirements.
• Define quality and validation requirements associated with process changes and collaborate with localteams on implementation.
• Interpret and apply applicable regulatory requirements, quality standards, and industry regulations.
• Identify, analyze, and lead continuous improvement initiatives focused on process and product qualityenhancement.
• Support internal and cross-functional teams in quality improvement and operational excellence activities.
• Ensure quality documentation is established, maintained, effective, and continuously improved.
• Coordinate complaint handling, root cause investigations, and corrective and preventive action (CAPA)activities.
• Participate in risk assessments related to processes, products, and design activities.
• Support regulatory, corporate, and external audits and inspections related to the Quality ManagementSystem.
• Conduct internal and supplier audits to verify compliance with quality requirements and standards.
• Ensure appropriate quality controls are implemented and maintained throughout manufacturingprocesses.
• Serve as a subject matter expert for quality processes, providing guidance and coaching to processowners and stakeholders.
• Maintain site document control and change control processes, ensuring compliance with localregulations and internal procedures.
• Review quality documentation, change controls, document archives, translations, and EDMS records forcompliance and accuracy.
• Support administration and maintenance of the electronic document management system (EDMS).

Skills, Knowledge & Expertise

Education: Bachelor’s degree in chemistry, Engineering, Quality, or a related discipline, postgraduate studies in Quality Management are preferred. Experience: Minimum 3+ years of experience in a quality or compliance role within medical devices or other regulated industries. Strong understanding of Quality System regulations including 21 CFR, ISO 13485, MDR 2017/745, and GMP.

Skills: Practical knowledge of problem-solving methodologies, production processes, validation methods, statistical analysis, Minitab, SPC, ISO 13485, and Microsoft Office tools including MS Project.

Communication: Strong written and verbal communication skills with the ability to synthesize and present information effectively. Fluent English communication skills are required.

Teamwork: Ability to collaborate across interdisciplinary teams, build strong relationships, work independently, and perform effectively in a fast-changing environment.

Complementary Skills

• Black Belt or Green Belt certification preferred.
• ISO 13485 Internal Auditor certification preferred.
• Goal-oriented mindset with strong interpersonal skills and the ability to manage multiple priorities under pressure.
• Experience with document control systems, change management processes, CAPA, audits, and continuous improvement initiatives.

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Equal Opportunity Statement

Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.